SUPPLY CHAIN ARTICLES

• “To Thine Own [mRNA Product] Be True:” Shakespeare's Guide To RNA GMP Principles

  In the following article, I offer some of the biggest tips and tricks experts offered during a panel discussion on the challenges of navigating GMP principles in the RNA space today — with a little bit of help from Shakespeare himself. 

• 5 Critical Regulatory Topics To Watch In The Oligo Sector

  Though our guidances have helped us achieve upwards of 20 commercially approved oligo products, as I listened to GSK’s director of CMC policy and advocacy, Katie Duncan, present at TIDES, it struck me just how far we have yet to come. Here, I single out a few of the biggest topics of regulatory discussion shaping the oligo therapeutics market.

• The RNA Therapeutics Supply Chain: A Platform of Relationships

  Conversations digging into RNA-specific sourcing considerations have been few and far between. Enter Sanofi's Greg Troiano. Together, we delved into the nuances, challenges, and opportunities for growth that currently exist within the mRNA drug substance and drug product (i.e., mRNA-LNP) raw material sourcing worlds.

• How Can We Move RNA Forward In Our Therapeutics Arsenal?

  RNA technologies, including mRNA therapeutics, have emerged as a promising drug modality. However, they have unique challenges. BioPhorum has dedicated a team to investigate these challenges and this Q&A shares their practical considerations for how to move this field forward.

• ARW's ATMP Manufacturing Must-Reads (ST. PATRICK'S DAY EDITION!)

  Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Once a month, I compile the articles and industry updates I think are most worthy of your time into an unconventional roundup article.

• Addressing Challenges In Serialization For Complex Therapeutics

  The magnitude of serialization, especially for firms with extensive portfolios and intricate supply chains, poses serious challenges. This discussion offers solutions.